U.S. patent number 6,585,704 [Application Number 09/772,506] was granted by the patent office on 2003-07-01 for method of retaining a tip protector on a needle with a curved tip.
This patent grant is currently assigned to B. Braun Medical, Inc.. Invention is credited to Charles W. Dickerson, Ronald B. Luther.
United States Patent |
6,585,704 |
Luther , et al. |
July 1, 2003 |
Method of retaining a tip protector on a needle with a curved
tip
Abstract
A system for retaining a tip protector on a needle having a
curved portion or bend adjacent the tip. A Braun clip tip protector
is used in combination with a small sleeve which fits around the
needle such that it is free to slide towards the needle tip until
stopped by the bend. In that stopped position, the tip protector
covers the tip but cannot slide off the end of the needle.
Inventors: |
Luther; Ronald B. (Newport
Beach, CA), Dickerson; Charles W. (Tustin, CA) |
Assignee: |
B. Braun Medical, Inc.
(Bethlehem, PA)
|
Family
ID: |
25095291 |
Appl.
No.: |
09/772,506 |
Filed: |
January 29, 2001 |
Current U.S.
Class: |
604/263; 128/919;
604/192; 604/198; 604/272 |
Current CPC
Class: |
A61B
17/3401 (20130101); A61M 5/3273 (20130101); A61M
2005/3247 (20130101); A61M 2005/325 (20130101); Y10S
128/919 (20130101); A61B 2090/08021 (20160201) |
Current International
Class: |
A61B
17/34 (20060101); A61B 19/00 (20060101); A61M
5/32 (20060101); A61M 005/00 () |
Field of
Search: |
;604/187,263,272,273,274,198,110,192,240 ;128/919 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gartenberg; Ehud
Assistant Examiner: Nicolas; Frederick C.
Attorney, Agent or Firm: Christie, Parker & Hale,
LLP
Claims
What is claimed is:
1. A device for protecting a sharp tip of a medical needle having a
bend in its shaft, comprising: a needle tip protector including a
protective portion configured to cover the needle tip to prevent a
person from being stuck by the tip, and including a slide portion
configured to slide along said shaft to a protective position in
which the protective portion covers the needle tip and the slide
portion is stopped by said bend to prevent the protective portion
from moving beyond the protective position, and wherein the bend
defines a first needle axis upstream of the bend and a second
different needle axis downstream of the bend.
2. The device of claim 1 wherein the slide portion further includes
a length that cooperates with an outer diameter of said shaft to
prohibit said slide portion from sliding beyond said bend.
3. The device of claim 2 wherein said slide portion has an inner
diameter which is between 0.0001 and 0.003 inch larger than the
needle outer diameter.
4. The device of claim 2 wherein said slide portion includes a
sleeve slidably mounted on said shaft.
5. The device of claim 4 wherein said sleeve and said tip protector
are formed integrally from a single piece of material.
6. The device of claim 4 wherein said sleeve has a substantially
elliptical cross section.
7. The device of claim 4 wherein said sleeve has a substantially
polygonal cross section.
8. The method of claim 1 wherein said protective portion is part of
a clip configured such that it could slide around the bend in the
needle if it were not for said slide portion.
9. A device comprising: a needle having a shaft with a bend
adjacent a sharp tip; a tip protector slidably mounted on said
shaft; a sleeve comprising a length sized such that it may slide
freely over said shaft, but may not slide around said bend, the
length of said sleeve being selected to stop said sleeve at a
location which prohibits said tip protector from sliding off said
needle and which allows said tip protector to cover said sharp tip;
and wherein the bend defines a first needle axis upstream of the
bend and a second different needle axis downstream of the bend.
10. The device of claim 9 wherein said sleeve is positioned between
a portion of said tip protector and said sharp tip.
11. The device of claim 10 wherein the inner diameter of said
sleeve is 0.0001 to 0.003 inches larger than the outer diameter of
said needle.
12. The device of claim 9 wherein said sleeve is substantially
rigidly attached to said tip protector.
13. The device of claim 9 wherein said sleeve and said tip
protector are formed integrally from a single piece of
material.
14. The device of claim 9 wherein said sleeves is attached to a
base of said tip protector on a side opposite said sharp tip.
15. A method of preventing needle stick for a needle having a bend
in its shaft adjacent a sharp tip of the needle, comprising the
steps of: positioning on the needle a tip protector having a
protective portion configured to cover the tip and a slide portion
configured to move on the needle towards the tip until it is
stopped by the bend; interengaging the protective portion with the
slide portion so that the protective portion covers the tip when
the movement of the slide portion towards the tip is stopped by the
bend; and wherein the bend defines a first needle axis upstream of
the bend and a second different needle axis downstream of the
bend.
16. The method of claim 15 including positioning the slide portion
between a portion of the protector and the needle tip.
17. A needle tip protector device comprising a spring clip having
an opening and a sleeve coaxially disposed over a needle having a
shaft and a bend in the shaft, wherein the sleeve comprises a
length and a cross-sectional dimension that are sized to be stopped
by the bend, and wherein the bend defined two different needle
axes.
18. The needle tip protector of claim 17, wherein the spring clip
further comprises an end wall, a first side, a second side, and at
least one arm extending in the direction of the second side of the
end wall, and wherein the sleeve is positioned adjacent the second
side of the end wall when coaxially disposed over the needle.
19. The needle tip protector of claim 17, wherein the spring clip
further comprises an end wall, a first side, a second side, and at
least one arm extending in the direction of the second side of the
end wall, and wherein the sleeve is positioned adjacent the first
side of the end wall when coaxially disposed over the needle.
20. The needle tip protector of claim 18, wherein the sleeve is
attached to the second side of the end wall.
21. The needle tip protector of claim 19, wherein the sleeve is
attached to the first side of the end wall.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates in general to needles with modified tips used
for example in spinal injections, and specifically to a method of
retaining a tip protector for such a needle.
2. Description of the Related Art
Historically in the medical field, needles have been necessary in
many procedures. Unfortunately the danger of accidental injury by
needles has increased due to the risk of transmission of various
blood borne diseases such as AIDS and Hepatitis. In many procedures
the use of needles has been reduced or eliminated, but there remain
many situations in which the use of a needle is unavoidable. In
these cases, it is desirable to limit the danger of accidental
injury to people by the needle as much as possible.
One such situation in which use of a needle has not been eliminated
is the insertion of catheters into a patient's vein. The catheter
is inserted into a patient's vein by a health care worker by using
a handheld placement device which includes a sharp-tipped needle.
The needle is positioned in the interior hollow portion of the
catheter with its tip extending slightly beyond the edge of the
catheter. The opposite end of the needle is connected to a hub
which is capable of being held by the health care worker.
Once the catheter has been inserted into the vein of the patient,
the needle is withdrawn, leaving the catheter in the patient's
vein. Once the needle has been removed from the catheter, however,
the sharp tip of the needle is exposed, and poses a threat to
anyone who handles it thereafter. With the needle tip exposed, the
health care worker or anyone else who handles the needle is in
danger of being accidentally pricked by the needle, and possibly
infected with any blood-borne diseases the patient may have been
carrying.
Bent needles such as Huber, Husted, and Touhy needles may be used
with similar catheters in procedures such as the injection of
spinal anesthetics where it is desirable to keep tissue from being
cored and jammed in the hollow tip of the needle. These needles are
often used in conjunction with stylets which are inserted into the
needle and block the opening in order to further help keep tissue
from jamming the needle. The stylet is a thin, flexible rod with a
tip shaped such that it provides a flat surface at the opening of
the needle. A hub at the end opposite the tip may be grasped and
used to remove the stylet from the hollow interior of the Huber or
other needle.
Many tip protectors have been developed for straight catheter
needles. One in particular as described in patent publication WO
99/08742 (also U.S. application Ser. No. 08/097,170) to Wynkoop et
al. describes a tip protector commercially referred to as the
"Braun clip." The Braun clip was developed for use with
over-the-needle intra-venous catheters as described above. This
particular device is adapted to fit within the hub of the catheter
such that when the needle is withdrawn from inside the catheter,
the Braun clip slides toward the sharp tip until it reaches a
retaining element which holds the clip from sliding completely off
the tip. The retaining element is positioned to stop the clip such
that its shielding portion covers the sharp tip of the needle.
When used with a typical I.V. catheter needle, the Braun clip is
retained from sliding off the end of the needle by crimping the
needle near the sharp tip. Unfortunately, needles such as the Huber
which are often used in conjunction with stylets cannot be crimped
due to the need for free movement of the stylet within the space
inside the hollow needle. Thus, it is desirable to have a method of
retaining a tip protector on a needle with a bent tip such as a
Huber needle.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a
method of retaining a tip protector on a needle with a bent or
otherwise modified tip which does not involve crimping or otherwise
altering the profile of the needle.
The present invention employs a tip protector device having a
protector portion and a portion that slides on the needle but
cannot slide past the needle bend and stops the protector portion
in the desired protective position. In the present invention a
preferred form of the slide portion includes a sleeve with an
internal diameter slightly larger than the needle's outer diameter.
The sleeve slides freely over the majority of the needle shaft, but
not around the needle bend and off the end of the tip. The
protector portion can be of a known clip type such as the Braun
clip.
The length of the sleeve is also an important dimension. It should
be such that the Braun clip is allowed to operate properly without
falling off the end of the tip. If the sleeve is too long, the clip
will be restrained from closing over the needle tip. If the sleeve
is too short, it may slide around the bend and off the tip. The
details of these dimensions and relationships are expanded in the
detailed description below.
One advantage of the use of a sleeve as described herein is its
ease of assembly. Once the sleeve has been properly sized, it can
be easily slid onto the shaft of the needle in operative
relationship with the Braun clip before attaching the needle hub or
before bending the tip. Another advantage is the low cost of the
part. A sleeve providing features and advantages of the present
invention can be produced very economically.
When used with an over-the-needle catheter, the tip protector and
the sleeve can initially be conveniently housed in a rear hub on
the catheter.
For purposes of summarizing the invention and the advantages
achieved over the prior art, certain objects and advantages of the
invention have been described above. Of course, it is to be
understood that not necessarily all such objects or advantages may
be achieved in accordance with any particular embodiment of the
invention. Thus, for example, those skilled in the art will
recognize that the invention may be embodied or carried out in a
manner that achieves or optimizes one advantage or group of
advantages as taught herein without necessarily achieving other
objects or advantages as may be taught or suggested herein.
All of these embodiments are intended to be within the scope of the
invention herein disclosed. These and other embodiments of the
present invention will become readily apparent to those skilled in
the art from the following detailed description of the preferred
embodiments having reference to the attached figures, the invention
not being limited to any particular preferred embodiment(s)
disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a Huber needle illustrating its
curvature.
FIG. 2 is a front view of the Huber needle of FIG. 1 showing a
stylet as it is typically positioned within the needle.
FIG. 3 is an orthogonal view of a Braun clip tip protector.
FIG. 4 is a side view of a tip protector and retaining sleeve
positioned along the shaft of the needle, and having features and
advantages of the present invention.
FIG. 5 is a side view of a tip protector and retaining sleeve
positioned so as to cover the sharp needle tip, and having features
and advantages of the present invention.
FIG. 6 illustrates an alternate relationship between the sleeve and
a tip protector.
FIG. 7 is a side view of the device of FIGS. 4 and 5 in combination
with an over-the-needle catheter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
FIGS. 1 and 2 show a Huber needle 32 characterized by a curve or
bend 20 in the tip. The bend allows the edge 38 of the opening 34
at the tip of the needle to be parallel to the axis of the needle
32. This helps to prevent tissue from being cored, and lodged in
the hollow needle, and thereby clogging it. This type of needle is
typically used in cases when a health care provider needs to inject
fluids, sometimes including drugs, into areas protected by
substantially hard tissues, such as the spine or the chest.
In order to additionally guard against tissue being cored by the
needle, a Huber needle is typically used with a stylet 30 as shown
in FIG. 2. The stylet 30 is typically a small, flexible rod which
slides into the hollow interior of the needle 32. The tip of the
stylet 30 is typically ground to a flat face 36 which is
substantially co-planar with the edge 38 surrounding the opening 34
of the needle 32. The features and advantages of the present
invention may also be realized in association with other types of
needles with bent tips, such as Husted or Touhy needles. These are
typically differentiated by the degree of their respective bends,
and the present invention may be practiced with these other needles
in the same manner as with the Huber needle.
An over-the-needle catheter 62 like the one shown in FIG. 7 is
typically used to inject fluids, often containing medicines into
the body of a patient. Over-the needle catheters are typically
formed from relatively flexible plastics, and are typically
disposed on a straight metal needle which is used to pierce the
skin and any other tissue in order to locate the open end of the
catheter in the particular part of the body to which the fluids are
to be delivered. In typical use, a Huber needle 32 with an
over-the-needle catheter 62 is grasped by the handle 71 and
inserted for example, into the spine. Once the health care provider
has determined that the tip 18 of the needle 32 and catheter 62 are
in the correct location, the needle 32 is withdrawn from the
patient (not shown), leaving the catheter 62 in the desired
location. According to the present invention, when the needle 32 is
withdrawn, a tip protector 10 and retaining slide or sleeve 12
preferably contained within the hub 60 of the catheter 62 will
preferably be slid to the tip 18 of the needle 32 and stop, thereby
covering the sharp tip 18 and protecting anyone handling the needle
32 from injury.
FIG. 3 shows a Braun clip 10 preferably punched from a
substantially resilient material which will allow the clip to be
substantially "springy" when used as described herein, and then
bent into the shape shown. Alternatively, the clip 10 may be
machined or cast, or made by any other process known to those
skilled in the art. The hole 14 in the base 13 of the clip 10 is
preferably sized such that it will fit over the needle 32 and allow
the clip 10 to slide freely along the needle 32. The distance from
the base 13 and the shielding portion 22 of the clip 10 can be
considered the operative length of the clip 10. The Braun clip 10
is schematically shown and described herein, and reference can also
be made to pending U.S. application Ser. No. 08/097,170 (also WO
99/08742) which is incorporated herein by reference.
FIGS. 4 and 5 illustrate the Braun clip tip protector 10 and the
retaining sleeve 12 as they are preferably disposed relative to one
another and the needle 32 in accordance with the present invention.
In FIG. 5 the shielding portion 22 of the clip 10 is covering the
sharp tip 18 of the needle 32.
The retaining sleeve 12 preferably has a substantially circular
cross section. Alternatively, the sleeve 12 may have any one of a
variety of cross-sectional shapes such as elliptical, triangular,
square, or any other polygonal shape providing that it functions as
described herein. The retaining sleeve 12 may be made from a
variety of substantially rigid materials, such as metal, glass, or
substantially rigid polymers.
The size of the retaining sleeve 12 is preferably determined by the
gauge of the needle 32, the size and angle of the bend 20, and the
size of the clip 10 being used. The inner diameter of the retaining
sleeve 12 is preferably 0.0001 to 0.003 inch larger than the outer
diameter of the needle 32. If the inner diameter of the sleeve 12
is too small, the sleeve 12 of course will not slide properly.
Conversely, if it is too large, the sleeve 12 will be allowed to
slide past the bend 20 of the needle 32, thus allowing the clip 10
to fall off and thereby failing to protect a person from the sharp
needle tip 18. The outer diameter of the sleeve 12 is preferably
larger than the hole 14 in the base 13 of the clip 10 (shown in
FIG. 3).
The sleeve 12 is preferably long enough that it is unable to slide
around the bend 20 in the needle 32, but short enough that it
allows the shielding portion 22 of the clip 10 to close over the
sharp tip of the needle 32. The clip 10 is also preferably
restrained from sliding far enough over the tip that the flanges 50
(shown in FIG. 3) pass the sharp tip 18 as this would allow the tip
to be exposed.
Referring to FIG. 5, the relationship between the various
dimensions of the clip 10 and the sleeve 12 are important to obtain
the described result. Proper dimensions are preferably chosen based
on the gauge of the needle 32 and the degree and length of the bend
20. The clip 10 and sleeve 12 are also preferably sized relative to
one-another such that they will perform as described herein. For
example, the distance between the sharp tip 18 of the needle 32 and
the sleeve bottom end 70, when the sleeve 12 reaches the position
at which it is stopped by the bend 20, should correspond with the
operative length of the Braun clip 10 in such a way that the two
lengths are substantially equal to one another (as shown in FIG.
5). The operative length of the clip 10 being defined as the
distance between the clip base 13 and the shielding portion 22 of
the clip 10.
The sleeve 12 is preferably held in operative relation to the clip
10 by the geometry of the clip 10 itself, and is preferably not
physically attached thereto. If desired, however, the sleeve 12 may
be glued, welded, or otherwise permanently bonded to the clip 10 in
the operative relationship shown and described herein.
Alternatively, the clip 10 and sleeve 12 may be formed integrally
from the same piece of material by machining, casting, or any other
method known to those skilled in the art.
In an alternative embodiment as shown in FIG. 6, the sleeve 12 may
be attached to the underside 76 of the base 13 of the clip 10. In
this embodiment, the operative length of the clip 10 should be
substantially equal to the distance between the end of the sleeve
12 attached to the clip underside 76 and the sharp tip 18 when the
sleeve 12 is in its stopped position. Thus, with a sleeve and clip
dimensioned like that of FIG. 5, the needle bend would have to be
spaced further from the tip. Of course, clip and sleeve dimensions
can be changed to fit a particular curved needle. The sleeve may be
bonded with a weld, glue or other known method, and it is
preferably made from a substantially rigid material such as
plastic, metal, glass, etc. This embodiment is useful when the bent
section of the needle is particularly long.
Thus, it may be seen that in either arrangement of FIGS. 5 or 6,
the sleeve 12 and the clip 10 are configured to interengage in a
manner that the sleeve stops movement of the clip in a position in
which the clip shielding portion 22 properly covers the needle
tip.
FIG. 7 illustrates a Braun clip-type protector 10 with a retaining
sleeve 12 and an over-the-needle catheter 62 in typical use. The
Braun clip 10 and the appropriately positioned retaining sleeve 12
are preferably contained within the hub 60 of the catheter 62 and
positioned at the base 52 of the needle 32 while the needle 32 and
catheter 62 are being inserted into the patient. When the needle 32
is withdrawn, the tip protector 10 and retaining sleeve 12 slide
along the shaft 16 of the needle 32 toward the tip 18 of the needle
32. When the tip protector 10 and retaining sleeve 12 reach the
position shown in FIG. 5, the retaining sleeve 12 is preferably
stopped by the bend 20 in the needle 32. The stopped sleeve 12 in
turn preferably stops the sliding of the clip 10 by contact between
the two at the clip base 13. In this position (as shown in FIG. 5),
the shielding portion 22 of the Braun clip 10 covers the sharp tip
18 of the needle 32 in order to guard a person from being
accidentally injured.
If desired, the clip 10 can be disengaged, and both parts 10 and 12
may be slid back down to the base 38 of the needle 32, and a
catheter 62 may be replaced. In order to move the clip 10 from the
position shown in FIG. 5 to that shown in FIG. 4, the health care
provider may pinch the sides 15 of the clip 10 until the two sides
of the shielding portion 22 are sufficiently separated that they
will allow the clip 10 to slide over the tip 18 and down the shaft
16 of the needle.
As will be recognized by those skilled in the art, the features and
advantages of the present invention may be realized in association
with any tip protector with which the invention is compatible, and
are not limited to the Braun clip tip protector.
Although this invention has been disclosed in the context of
certain preferred embodiments and examples, it will be understood
by those skilled in the art that the present invention extends
beyond the specifically disclosed embodiments to other alternative
embodiments and/or uses of the invention and obvious modifications
and equivalents thereof. Thus, it is intended that the scope of the
present invention herein disclosed should not be limited by the
particular disclosed embodiments described above, but should be
determined only by a fair reading of the claims that follow.
* * * * *